This Phase IIb trial will compare effectiveness and safety of a multi-component autoantibody reduction therapy (AART), consisting of therapeutic plasma exchange (TPE), rituximab, and intravenous immunoglobulin (IVIg) for treatment of patients with progressive idiopathic pulmonary fibrosis (IPF).
Patients with progressive pulmonary fibrosis, identified at any of nine participating leading U.S. medical centers, will be randomized (by computer) in a 1:1 ratio to either AART or treatment as usual (TAU). Stratification factors for randomization are sex (self-identified) and whether or not patients are taking any IPF-approved medication. Patients will be observed for six (6) months, with observations and assessments made at baseline, 30 days after randomization, and 90 and 180 days after randomization. Data will be electronically submitted via electronic case report forms (eCRF) to a Data Coordinating Center. The University of Alabama Medical Center Institutional Review Board (IRB) will be the central IRB for all sites. Specimens collected will also be used in experimental B-cell studies conducted in the laboratory of the Principal Investigator.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Removal of patient's plasma by mechanical means and replacement with saline and albumin or normal plasma
Infusion of humanized mouse monoclonal antibody with specificity for human CD20
intravenous infusions of normal human immunoglobulin
University of Alabama at Birmingham
Birmingham, Alabama, United States
Loyola University
Chicago, Illinois, United States
Northwestern University
Chicago, Illinois, United States
University of Kansas
Forced Vital Capacity (FVC)
Intergroup comparisons of FVC changes over duration of observations
Time frame: 180 days or latest available observation (e.g., at 30, 90, or 180 days after randomization)
Supplemental Oxygen Requirements (O2)
Intergroup comparisons of changing O2 requirements over duration of observations
Time frame: 180 days or latest available observation (e.g., at 30, 90, or 180 days after randomization)
Six-minute walk distances (6MWD)
Intergroup comparisons of changes of 6MWD over duration of observations
Time frame: 180 days or latest available observation (e.g., at 30, 90, or 180 days after randomization)
Durations of progression-free survival
Intergroup comparisons of number who survive without \>5% decrements of FVC as percent of predicted normal values
Time frame: 180 days or latest available observation (e.g., at 30, 90, or 180 days after randomization)
Composite outcome measure
Absolute numbers of acute IPF exacerbations or all cause deaths or unscheduled hospitalizations
Time frame: 180 days or latest available observation (e.g., at 30, 90, or 180 days after randomization)
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Continued therapy with conventional, approved, specific IPF medications
Kansas City, Kansas, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Temple University
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
University of Utah
Salt Lake City, Utah, United States